This phase II trial studies how well Proliferation Saturation Index determined radiation therapy works in treating patients with head and neck cancer. Mathematical models, such as the Proliferation Saturation Index, can be used to divide the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. This mathematical model may help to better choose a radiation method to improve the rate of response in patients with head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03656133.
PRIMARY OBJECTIVE:
I. To increase the rate of response of >= 32% at 20 days to 63% of patients, above the expected 49%.
SECONDARY OBJECTIVES:
I. Rate of complete response by computed tomography (CT) at 2 months or positron emission tomography (PET)/CT at 3 months following completion of therapy.
II. Correlate response and outcome to pre-treatment and during treatment radiomics features on PET/CT/magnetic resonance imaging (MRI).
III. Correlate response and outcome to mathematical models of tumor growth and death dynamics pre-treatment and during treatment.
IV. Correlate radiosensitivity index (RSI)/genomic-adjusted radiation dose (GARD) with mid-treatment and post-treatment response.
V. Correlate clearance of human papillomavirus (HPV) in serum/oral gargle specimens with mid-treatment and post-treatment response.
EXPLORATORY OBJECTIVE:
I. Identify potential biomarkers of response to adaptive radiation therapy based on evaluation of tumor immune microenvironment and detection of HPV deoxyribonucleic acid (DNA) in oral gargles.
OUTLINE: Patients undergo standard pre-treatment scans to calculate the Proliferation Saturation Index (PSI) and are then assigned to 1 of 2 cohorts.
COHORT I: Patients undergo conventional fractionation radiation therapy once daily (QD) Monday-Friday for 6 weeks in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients undergo hyperfractionated radiation therapy twice daily (BID), at least 6 hours apart, Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, 2-3 months, 6 months, and 12 months.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorJimmy J. Caudell
